Blood Vessel Patterns in Small Choroidal Tumors

NCT ID: NCT01955915

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2023-12-31

Brief Summary

The purpose of this study is to see if mapping blood vessel patterns with optical coherence tomography (OCT) will help identify life-threatening choroidal tumors in their early stages and improve overall patient survival through early detection.

Detailed Description

Uveal melanomas are melanocytic tumors that arise in the pigmented tissues of the eye: the iris, ciliary body, and choroid. Iris melanomas rarely metastasize (spread to other tissues or organs). In contrast, uveal melanomas arising in the ciliary body and choroid are highly malignant (cancerous and invasive to other tissues or organs). Despite having excellent local tumor control rates, uveal melanoma remains a life-threatening cancer, and even eye-sparing therapy with radiation treatment often leads to significant loss of vision. Therefore patients diagnosed with uveal melanoma must cope with not only a life-threatening illness, but also the frightening prospect of significant vision loss. Choroidal melanomas located in the posterior pole, an anatomical area of the eye which includes the optic nerve and macula (central retina), are of particular concern with regards to visual outcome, as radiation treatment to these areas for even the smallest of tumors is often associated with severe vision loss. The accurate diagnosis and treatment of small choroidal melanomas is critical to patient survival. When tumors with metastatic potential are recognized and treated at an early stage, survival prognosis improves dramatically.

The purpose of this study is to learn if malignant (life-threatening) choroidal tumors versus benign (non-life-threatening) tumors will show distinct blood vessel patterns using functional optical coherence tomography (OCT) angiography. Angiography is the mapping of blood vessels. The investigators believe that OCT angiography can provide data which may help in identifying life-threatening tumors at the earliest stages and improve overall survival for patients with this type of melanoma.

Conditions

Small Posterior Choroidal Tumors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Choroidal Tumor Group

15 patients diagnosed with small posterior choroidal tumors will be considered and evaluated for enrollment into this study

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adults older than age 18 with small (< 3mm) choroidal tumors located within the posterior pole region which can be imaged using OCT technology. Subjects with benign-appearing and malignant-appearing lesions meeting these criteria will be enrolled.

Exclusion Criteria

• Inability to give informed consent.
• Inability to maintain stable fixation for OCT imaging.
• Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
• Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
• Women who are pregnant or lactating at the time of enrollment due to unknown safety of fluorescein angiography. Women that become pregnant during the course of the study may remain enrolled; however, flurorescein and ICG angiography will not be performed until they are no longer pregnant or nursing an infant.
• Patients receiving treatment for uveal melanomas will be excluded from the longitudinal natural history portion of this study, but may enroll for a single study visit prior to treatment of their melanoma. They will then be eligible to enroll in IRB 9501, which will follow radiation-treated patients longitudinally.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Alison Skalet

Alison Skalet, MD, PhD, Assistant Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alilson Skalet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

IRB#00009475

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00009475

Identifier Type: -

Identifier Source: org_study_id